510(k) · Cleared
ClearedDBX Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Transplant Foundation · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Feb 5, 2007 as substantially equivalent to K042829 (Musculoskeletal Transplant Foundation, 2006) after a 188-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it.
- Decided
- Feb 5, 2007
- Review
- 188 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042829 (2006). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK042829 DBX StripMusculoskeletal Transplant Foundation · 2006
- This deviceK062205 DBX StripMusculoskeletal Transplant Foundation · 2007
- Descendant · cites it directly · 3 of its ownK113167 MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
- Descendant · cites it directly · 3 of its ownK110003 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011
- Descendant · 2 generations on · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK151271 BellaFuseHans Biomed Corp. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012 · cites it directly3descendants
- K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011 · cites it directly3descendants
- K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc. · 2012 · 2 generations on1descendant
- K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025 · 3 generations on0descendants
- K151271BellaFuseHans Biomed Corp. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042829 | DBX Strip | Musculoskeletal Transplant Foundation | 2006 | — |
| 0 (this device) | K062205 | DBX Strip | Musculoskeletal Transplant Foundation | 2007 | — |
| +1 | K113167 | MTF New Bone Voild Filler | Musculoskeletal Transplant Foundation | 2012 | — |
| +1 | K110003 | MTF New Bone Void Filler | Musculoskeletal Transplant Foundation | 2011 | — |
| +2 | K121989 | Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +… | Exactech, Inc. | 2012 | — |
| +3 | K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | 2025 | — |
| +1 | K151271 | BellaFuse | Hans Biomed Corp. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042829 | DBX StripSummary page 2…e origin). DBX8 Strip is for single patient use only and is available in five sizes. SUBSTANTIAL EQUIVALENCE INFORMATION: DBX® Strip was cleared by FDA (K042829) as a bone void filler for use in the posterolateral spine. The new DBX® Strip is substantially equivalent to DBX® Strip, FDA cle… | 2006 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
DBX® Strip is indicated as a bone void filler for treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the pelvis, extremities, and the posterolateral spine for posterolateral fusion. DBX® Strip, when used for posterolateral spine fusion, may be used with autograft.
DBX ®Strip is for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062205 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062205: DBX Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062205
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026